For several years, Trebing + Himstedt has been active regarding 21 CFR Part 11, providing our own seminars and consulting, as well as being an active member in GAMP D-A-CH SIG ER/ES, VDMA und ISPE.

With RAPID-Pharma, we have successfully completed numerous projects with 21 CFR Part 11 focus.

Our articles on 21 CFR Part 11 can be found in the press release section:
Press Releases

Further information:
Download: RAPID-Pharma_21CFRPart11.pdf (145 kb)

PAT Requirements on Modern IT Systems and Implementation Strategies

With publication of the draft »PAT - a Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance«, the US Federal Drug Administration (FDA) put forward a proposal to establish an innovative pharma production with reproducible and high quality, with PAT standing for »Process Analytical Technology«. Upon PAT implementation as a system for analysis and control of the pharmaceutical manufacturing process on the basis of permanent recording of critical quality-relevant parameters, companies are confronted with numerous obstacles in practice. PAT consists or two components. On the one hand, there is a set of scientific principles and tools allowing innovation. On the other hand, it is a strategy enabling innovation and at the same time combining it with regulatory requirements. Besides these challenges, it is essential to develop a »PAT culture«, the respective adapted organizational structures and new communication forms with supervisory bodies inside and throughout the company.

PAT initiatives require a technical framework in order to connect the various processes from R&D via production up to quality assurance. The management of the extremely large information volume throughout the entire life cycle calls for the most modern tools and methods of information technology. In the PAT guideline, the FDA recommends the employment and interlinking of various categories of tools and methods for process analysis, online and inline chemial analysis and knowledge management.
The following PAT tool categories have been cited by the FDA:

• Multivariate data acquisition and analysis tools
• Modern process analysers, process analytical chemistry tools
• Process and endpoint monitoring and control tools
• Continuous improvement und knowledge management tools